Analytical Development Senior Scientist (Potency Assay)
Esco Lifesciences Group provides enabling technologies, products and services to the life sciences and healthcare industries, supporting academic research and scientific discoveries, clinical practice, as well as biopharmaceutical R&D and manufacturing. Headquartered in Singapore, Esco has an extensive sales network in over 100 countries, direct sales and service offices in over 24 countries, 8 manufacturing and R&D hubs in the US, Europe, the UK, China, Singapore, Indonesia, and over 1500 employees worldwide.
Esco is poised to benefit from the sustained growth of the healthcare and biopharma industries in Asia and globally. Esco has achieved market leadership in China, and globally, in multiple categories within some of the fastest-growing segments — with China being its largest and fastest growing market. As a Singapore-headquartered company, Esco is a nexus of East and West, bridging technologies, products and talent across the world, with global operations spanning the US, Europe and Asia.
Physical/Mental Requirements/Work Environment
- Ability to read, analyze and interpret scientific data and publications.
- Ability to author or review protocols, technical reports and technology transfer documents.
- Ability to author or review standard operating procedures and other related documents.
- Ability to define problems, collect data, establish facts, and draw conclusions.
- Ability to focus.
- Repetitive motions due to certain laboratory techniques.
- Ability to adapt and keep up with rapid changes in a fluid and dynamic environment as this is a rapidly evolving space.
- Develop, validate, and execute scientifically and regulatory defendable cell based and associated potency assays across our different modalities including analysis of such potency assays using biochemistry / bioassay techniques such as LC-MS/MS, HPLC, SWATH-MS/MS-omics, or otherwise for in vitro and in vivo assays for small molecules, nanoparticles (mRNA-LNP/exosomes/extracellular vesicles (EVs)/biopolymers) and other frontier biology modalities in compliance to ICH and GLP guidelines.
- Develop analytical target profile as per analytical life cycle development to identify intension of method, method consistency and ensure repeatability across method parameters/ instruments including orthogonal method analysis.
- Ensure potency assays are a direct measure of mechanism of action and establish a clear correlation of measured activity and biological effect. Ability to determine degradation of sample(s) during measured activity is essential.
- Ensure potency assays are part of quality by design (QbD) across entire process lifecycle.
- Ensure lot to lot consistency and ability to measure strength, stability, and therapeutic activity/relevant critical quality attributes (CQA) and product attributes.
- Ensure compliance to GLP standards and perform method development, and method validation. Internally tech transfer validated methods to central QC laboratory.
- Design and plan bioassay or animal studies (PK/PD) and oversee external CROs on outsourcing such studies.
- Ability to understand and interpret data from ADMET assays.
- Utilize LC-MS/MS to analyze primary tissues such as tumors to develop neoantigen personalized peptides and peptidomics, working with bioinformatics teams and related potency assays.
- Function as subject method expert for LC-MS/MS and develop training material and utilize it for other -omics work including toxicology for novel foods and sensomics working with our food scientists.
- Write technical documents in compliance to GLP/Esco Aster QMS such as but not limited to technical reports, SOPS, training qualification manuals, white papers, and others.
- Manage, mentor a small team, and eventually build up an overall team.
- Perform other tasks as assigned from senior leadership team.
- PhD with 2-4 years of experience or a Masters/Bachelor degree with 4-8 years of experience in Biochemistry, Immunology, Molecular Biology or similar discipline.
- Effective communication is essential and that includes internal presentations as well as presentations to collaborators/clients.
- Some experience with cell culture techniques including cell passaging, culture and counting is desirable.
- Experience with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) will be an advantage.
- Ability to plan and perform experiments in an interdisciplinary environment independently and efficiently.
- Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel).
- Able to work independently, self-starter, self-motivated and task oriented.
- Strong team player, develop positive relationship with a strong set of interpersonal skills.
- During the start-up phase of the team/facility, be willing to take on expanded role to set up workflow/processes as needed.
Apply now by submitting a Cover Letter and CV to [email protected].